The invention generally relates to packages and containers for medication, and more particularly, to a medication package and associated method for anti-diversion detection and compliance monitoring.
Adherence to prescription medication dosing schedules is often problematic for both the patient and the physician. Forgetting to take medications, or non-compliance, results in poor patient outcome and often is not reported to the prescribing physician by the patient. This can result in the physician increasing the dosage or changing to a different class of medication because of apparent ineffectiveness. Conversely, the taking of medications too frequently, or abuse, can have dangerous consequences for the patient. There is also a problem with diversion of the medication. Hereinafter, “diversion” will be used to refer the diversion of a medication with abuse potential from the intended legitimate patient population to an illicit market. The non-medical use and diversion of prescription drugs such as opioids, stimulants and central nervous system depressants can lead to abuse, addiction, and even death. While doctors and pharmacists often attempt to assure medications are being dispensed and used as prescribed, diversion of medications to the illicit market has risen to unprecedented levels. Currently, there are no, or inadequate, effective measures in place to counteract the problems that allow diversion of medications with abuse potential.
It is well known that prescription drugs relieve symptoms for millions of people and allow those who suffer from chronic syndromes to lead productive lives. Unfortunately, non-compliance is common in many disease syndromes such as schizophrenia, depression and dementia. It is intuitive that non-compliance translates into additional cost to our health care system. Additionally, most people who use medications do so responsibly; however, the non-medical use of prescription drugs, especially pain medications, has become a serious public health concern. Non-medical use of drugs such as opioids, stimulants and central nervous system depressants can lead to abuse, addiction, and even death. Consequently, communities are finding their limited social and financial resources overwhelmed by the high cost of rehabilitating those who become addicted to one of these medications. In addition, crime rates have risen dramatically in those geographic areas endemic with abuse of these medications. According to the “National Household Survey on Drug Abuse,” 1999, there were an estimated 4,000,000 people were using prescription drugs non-medically in that year. That survey found that, of these, 2.6 million misused pain relievers, 1.3 million misused sedatives and tranquilizers, and 0.9 million misused stimulants. Furthermore, this illicit diversion of medications has resulted in unnecessary expense to medical insurance carriers, a significant factor in our cost driven health care system. As provided in a 1999 report by the “Substance Abuse and Mental Health Services Administration” (SAMHSA), visits to hospital emergency departments due to abuse of one particular pain medication, hydrocodone, increased 37% from 1997 to 1999. Aside from the obvious problem addiction causes the patient, many of these cases also result in expensive litigation costs to the drug manufacturer, physician and the malpractice liability insurance carriers. While doctors and pharmacists currently attempt to assure medications are being dispensed and used as prescribed, diversion of medications to the illicit market has risen to unprecedented levels. The total cost to the U.S. economy associated with diversion of prescription medications is estimated to be 1.77 billion dollars annually.
Prescribing physicians and pharmacists have little at their disposal to prevent non-compliance, abuse, and diversion, other than the word of the patient that the medications are being sought and taken in a legitimate fashion and as prescribed. Patients, for example, who receive prescription drugs legitimately may inadvertently or intentionally take them too frequently, which may result in abuse or addiction. Additionally, a patient may obtain prescriptions for a pain reliever from multiple doctors simultaneously in an attempt to abuse the medication or sell it illegally. Known as “doctor-shopping,” this practice continues because current prescription monitoring programs are inefficient and ineffective. At follow-up office visits the prescribing physician has no way of monitoring whether any doses were removed from the package ahead of time, which could suggest abuse or diversion is occurring. There are also reported cases of unscrupulous doctors financially motivated to wantonly write prescriptions or directly supply pain relievers to patients for cash. Other examples of diversion are theft of pain relievers by pharmacy employees, falsification of medication inventory by pharmacy employees and theft of prescription pads from doctors' offices.
According to a March 2001 report by “Alliance of States with Prescription Monitoring Programs,” there are currently 17 states that have central prescription-monitoring (PM) programs. However these programs established to counteract diversion can be ineffectual due to multiple factors, such as, for example, the following:                The transfer of patient and prescription information from the pharmacy to the PM database at the time the medication is dispensed is manually entered by the pharmacist. This process is slow, inefficient, allows for human error with regard to data entry and is not in ‘real-time’.        The current PM programs require months to process the data received from the pharmacies. The lack of a ‘real-time’ database allows diversion to continue because the dispensing pharmacy has no way of communicating with other pharmacies to determine, for example, if the patient had filled similar prescriptions obtained from different doctors that day.        Pharmacies are mandated by law to perform monthly inventories of all medications with abuse potential and report this data to the managing agency overseeing the PM program. This depends on the pharmacist entering truthful and valid inventory data, which is unlikely to occur if the pharmacists themselves are diverting the medications for profit.        Patients by law can only be prescribed one-month supplies, with no refills, of medications with abuse potential such as pain relievers or stimulants. This requires the patient to return to their doctor monthly for subsequent prescription renewals. The physician has no way of knowing at these follow-up office visits if the pills were taken as prescribed during the previous month. Currently, for example, a patient can remove all the pills from the bottle on the day the prescription is filled and sell them, or take them too frequently and become addicted.        There have been numerous examples of unscrupulous doctors prescribing medications with abuse potential in a profit-seeking manner. The current PM programs have allowed this illegal activity to continue, often for years before the trend is detected, due to the slow dissemination of information to the central database.        Patients currently steal prescription pads or forge legitimately obtained prescriptions. Current PM programs are unable to detect this illegal activity.        
It is known in the art to provide packages, containers, dispensers, and the like which have provisions for dispensing individual doses of medication and have audible reminders of dosing times. Such a device is described in, for example, U.S. Pat. No. 4,617,557. It is also known to obtain and provide compliance data to prescribing physicians for review, as described in, for example, U.S. Pat. No. 6,198,383. However, it is not known to address the aforementioned issues that allow abuse, addiction and diversion of prescription medications to illicit use. Additionally, such medication packages may not sufficient incorporate child-resistant features. Furthermore, in regard to the patent referenced above which addresses compliance issues, the device described therein employs conductive traces that must be broken to detect removal of the medication from the package. This can result in decreased battery life of the medication package, and an increased number of required inputs to the central processing unit (CPU) in the medication package, thereby increasing the packaging cost.
Accordingly, there is a need for a medication packaging system which has improved packaging, including child resistant features and longer battery life, and which further incorporates both anti-diversion capabilities and compliance monitoring functions.